BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PRO M CLASS

    DI: 08809394971352 · Model: PRO M CLASS · SAEYANG MICROTECH CO.,LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PRO M CLASS
    Primary DI
    08809394971352
    Version / Model
    PRO M CLASS
    Company Name
    SAEYANG MICROTECH CO.,LTD
    Labeler DUNS
    631078094
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-07
    Public Version
    1
    Public Version Date
    2023-06-15
    Public Version Status
    New
    Public Device Record Key
    971092ba-aab8-4f81-936c-6b727affc32a

    Device Description

    The PRO M CLASS is an AC-powered device that includes a "Motor Handpiece","Contra angle Handpiece","Charger unit" and "AC/DC Adaptor" for grinding, cutting, polishing and screw driver work in dental oral use.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EKX Handpiece, Direct Drive, Ac-Powered

    GMDN Terms

    Code Name
    66227 Dental surgical power tool motor, electric

    Identifiers

    Type ID
    Primary 08809394971352

    Premarket Submissions

    Submission Number Supplement Number
    K213897 000